Biovail Corporation and Watson Pharmaceuticals, Inc said they have reached a settlement agreement over a patent dispute regarding the generic version of Cardizem LA, Biovail's once-daily formulation of diltiazem. As per the terms of the agreement the drug will delay hitting the market until April 1, 2009.
Biovail filed suit against Watson subsidiary Andrx Pharmaceuticals, Inc. over its plans to make a generic version of Cardizem, a blood pressure drug for the treatment of hypertension. Andrx had filed abbreviated new drug application for the generic with the federal regulators earlier.
Under the terms of the settlement agreement, BLS will receive a royalty based on sales of Watson's generic formulation of Biovail's Cardizem LA. The agreement generally provides that Watson will not commence marketing and sales of its generic equivalent product earlier than April 1, 2009, at which time royalty payments will begin. As part of the settlement, Biovail has granted Watson an exclusive license to its US patents covering Cardizem LA for a generic version of Cardizem LA.
Other details concerning the settlement have not been disclosed.
The settlement is subject to court approval, and will be submitted to the Assistant Attorney General in charge of the Antitrust Division of the Department of Justice and the Federal Trade Commission within 10 days of its execution.
Biovail Corporation is a specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, and commercialisation of pharmaceutical products utilizing advanced drug-delivery technologies.